Device and Method for Gaining Access into a Body Cavity

Abstract

A device and methodology for gaining access into a body cavity of a patient is described and which includes an elongated sheath; an elongated dilator which is telescopingly received in the sheath, and wherein the elongated dilator has a distal end which is received within a body cavity to be accessed, a selectively inflatable occlusion balloon mounted on the dilator, and first and second sources of pressurized fluid which is coupled in fluid flowing relation relative to the dilator, and which further is effective, on the one hand, for inflating the occlusion balloon, and secondly for delivery into the body cavity of the patient based on the desires of a clinician.

We claim: 
     
         1 . A device for gaining access into a body cavity, comprising:
 an elongated sheath having opposite ends, and further defining a longitudinally oriented passageway which extends between the opposite ends;   an elongated dilator having a main body with opposite ends, and which is telescopingly received within the longitudinally extending passageway which is defined by the sheath, and wherein the dilator defines a longitudinally oriented lumen which extends between the opposite ends thereof, and further has a first and second passageway which is formed in the main body of the elongated dilator;   a selectively inflatable occlusion balloon mounted on the dilator, and which is coupled in fluid flowing relation relative to the first passageway which is defined by the elongated dilator;   a first source of pressurized fluid which is coupled in fluid flowing relation relative to the first passageway; and   a second source of pressurized fluid which is coupled in fluid flowing relation relative to the second passageway.   
     
     
         2 . A device as claimed in  claim 1 , and wherein the opposite ends of the sheath includes a proximal, first end, and a distal, second end, and wherein the sheath has an inside facing surface which defines the longitudinally oriented passageway, and wherein the longitudinally oriented passageway has a predetermined, and substantially uniform inside diametral dimension, and wherein the elongated sheath has an exterior facing surface, and the second passageway is defined, at least in part, by the exterior surface, and wherein the device further includes a fluid coupling which is mounted on the exterior facing surface of the sheath, and is further located at first end of the sheath, and which further fluid flowingly couples the first and second sources of pressurized fluids to each of the first and second passageways which are defined by the dilator. 
     
     
         3 . A device as claimed in  claim 2 , and wherein the exterior facing surface of the elongated sheath is narrowly cylindrical, and wherein the fluid coupling is at least partially rotatable relative to the exterior facing surface of the sheath, and wherein the partial rotation of the fluid coupling relative to the sheath selectively couples each of the first and second sources of pressurized fluid in fluid flowing relation relative to the respective, first and second passageways which are defined by the main body of the dilator. 
     
     
         4 . A device as claimed in  claim 3 , and wherein the opposite ends of the dilator includes a first end which is located in spaced relation relative to the first end of the sheath, and a second end which, when assembled with the sheath, is located in spaced relation relative to the second end of the sheath, and wherein the dilator has an outside diametral dimension which is less than the inside diametral dimension of the longitudinally oriented passageway as defined by the sheath, and wherein the dilator is selectively, reciprocally moveable relative to the sheath, and wherein the occlusion balloon is mounted at a location which is between the first and second ends of the dilator, and the second passageway which is defined by the main body of the dilator extends from the first end of the dilator, and terminates at a location which is in an adjacent, closely spaced relationship relative to the occlusion balloon, and wherein the dilator is longitudinally advanced relative to the sheath to a location where the occlusion balloon, and a terminal portion of the second passageway are each oriented longitudinally, outwardly, relative to the second end of the sheath. 
     
     
         5 . A device as claimed in  claim 4 , and wherein the first source of the pressurized fluid is effective, when delivered to the first passageway, to inflate the occlusion balloon to a predetermined outside diametral dimension which at least partially occludes a body cavity of a patient. 
     
     
         6 . A device as claimed in  claim 4 , and wherein the second source of pressurized fluid comprises a liquid which is delivered, at least in part, into a body cavity of a patient. 
     
     
         7 . A device as claimed in  claim 4 , and wherein the sheath has an interior facing surface which defines the longitudinally extending passageway, and wherein the second passageway which is defined by the dilator is defined, at least in part, by the interior facing surface of the sheath. 
     
     
         8 . A device as claimed in  claim 4 , and wherein the body cavity may include a fistula or other blood vessel, and wherein the occlusion balloon is inflated so as to effect a reflux angiogram of an arterial anastomosis of a patient. 
     
     
         9 . A device as claimed in  claim 4 , and wherein the second end of the dilator, the occlusion balloon, and the terminal end of the second passageway, are each sized so as to be received within a body cavity of a patient. 
     
     
         10 . A device as claimed in  claim 4 , and wherein the main body of the elongated dilator is flexible, and the second end of the dilator is stiff so as assist in the insertion of the second end of the dilator into a body cavity of a patient. 
     
     
         11 . A device for gaining access into a body cavity, comprising:
 an elongated sheath having opposite first, and second ends, an exterior facing surface, and a longitudinally extending passageway which extends between the opposite first and second ends, and wherein the longitudinally extending passageway has a predetermined inside diametral dimension;   an elongated dilator having a main body which has an outside diametral dimension which is less than the inside diametral dimension of the longitudinally extending passageway which is defined by the elongated sheath, and wherein the main body of the elongated dilator further has opposite, first and second ends, and wherein the second end of the dilator is received within a body cavity of a patient, and wherein the main body of the elongated dilator has a longitudinally oriented lumen which extends between the opposite first and second ends of the main body, and wherein the elongated dilator is further telescopingly received within the longitudinally extending passageway of the sheath, and is further reciprocally and longitudinally moveable relative to the elongated sheath, and wherein the main body of the elongated dilator further has an outside facing surface, and wherein a first and second passageway is individually formed in the main body of the elongated dilator, and which further, respectively, extend from the first end thereof, and in the direction of the second end of the main body, and wherein each of the first and second passageways have a proximal, and a distal end;   a selectively inflatable occlusion balloon mounted on the dilator at a location which is intermediate the first and second ends of the main body thereof, and wherein the dilator balloon is coupled in selective, fluid flowing relation relative to the first passageway which is formed in the main body of the elongated dilator, and wherein the occlusion balloon can be inflated when the elongated dilator is longitudinally advanced to a position where the occlusion balloon is located longitudinally, outwardly, relative to the second end of the elongated sheath, and wherein the second passageway which is formed in the main body of the dilator, and further defined, at least in part, by the exterior facing surface thereof, extends from the first end of the dilator in the direction of the second end of the dilator, and wherein the distal end of the second passageway terminates at a location which is adjacent to, but short of the selectively inflatable occlusion balloon, and wherein the main body of the elongated dilator can be longitudinally advanced relative to the sheath so as to position both the occlusion balloon, and the distal end of the second passageway which is formed in the main body of the elongated dilator, at a location which is longitudinally, outwardly relative to the second end of the sheath;   a first source of a pressurized fluid which is coupled in selective fluid delivering relation relative to the proximal end of the first passageway, and which is defined by the elongated dilator, and wherein the first source of pressurized fluid, when delivered to the first passageway is effective in inflating the occlusion balloon; and   a second source of a pressurized fluid which is coupled in selective, fluid delivering relation relative to the proximal end of the second passageway of the elongated dilator, and which further, when delivered to the second passageway, travels to the distal end thereof, and then exists the elongated dilator in a direction which is oriented laterally, outwardly relative thereto.   
     
     
         12 . A device as claimed in  claim 11 , and wherein the elongated sheath has an interior facing surface, and the second passageway is defined, at least in part, by the interior facing surface of the elongated sheath, and wherein the device further includes a first fluid coupling portion which is mounted on the exterior facing surface of the sheath, and is further located at the first end of the sheath, and which further selectively fluid flowingly couples the second source of the pressurized fluid to the second passageway which is defined by the dilator. 
     
     
         13 . A device as claimed in  claim 12 , and wherein, and wherein the dilator includes a second fluid coupling portion which is oriented in fluid delivering relation relative to the first passageway thereof, and wherein the first source of pressurized fluid is delivered to the first passageway so as to effect an inflation of the occlusion balloon. 
     
     
         14 . A device as claimed in  claim 13 , and wherein the body cavity may include a fistula or other blood vessel, and wherein the occlusion balloon is inflated so as to effect a reflux angiogram of an arterial anastomosis of a patient. 
     
     
         15 . A method for gaining access to a body cavity, comprising:
 selecting a body cavity for access;   inserting a needle, at least in part, into the selected body cavity, and wherein the needle defines a longitudinally oriented passageway extending therethrough;   inserting a wire into the longitudinally oriented passageway, and orienting the wire in a given location within the selected body cavity;   removing the needle from the body cavity while maintaining the wire within the selected body cavity;   providing a sheath having a main body which defines a longitudinally extending passageway having a predetermined inside diametral dimension, and extending the wire through the longitudinally extending passageway;   movably advancing the sheath along the wire, and inserting at least a portion of the sheath into the selected body cavity;   removing the wire from the selected body cavity while maintaining at least a portion of the sheath within the selected body cavity;   providing a dilator with a main body which defines a longitudinally extending lumen, and first and second passageways, and telescopingly orienting the main body of the dilator within the longitudinally extending passageway which is defined by the sheath, and inserting, at least in part, a portion of the main body of the dilator within the selected body cavity;   mounting a selectively inflatable occlusion balloon in a given location on the main body of the dilator, and coupling the occlusion balloon in fluid flowing relation relative to the first passageway as defined by the dilator;   selectively coupling a first source of a pressurized fluid to the first passageway which is defined by the dilator, and delivering the first source of the pressurized fluid to the first passageway so as to effect an inflation of the occlusion balloon within the selected body cavity; and   selectively coupling a second source of a pressurized fluid to the second passageway, and delivering the second source of the pressurized fluid by way of the second passageway to the selected body cavity.   
     
     
         16 . A method as claimed in  claim 15 , and wherein the sheath has opposite first and second ends, an inside facing surface which defines the longitudinally extending passageway, and an exterior facing surface, and wherein the dilator has opposite first and second ends, and an exterior facing surface, and wherein the second passageway is formed, at least in part, by the exterior facing surface of the dilator, and wherein the inside facing surface of the sheath forms, at least in part, a portion of the second passageway when the dilator is telescopingly oriented within the longitudinally extending passageway of the sheath. 
     
     
         17 . A method as claimed in  claim 16 , and wherein the step of mounting the selectively inflatable balloon takes place at a location which is between the first and second ends of the main body of the dilator, and wherein the second passageway has a terminal end which is positioned adjacent to the occlusion balloon. 
     
     
         18 . A method as claimed in  claim 17 , and which further comprises:
 after the step of mounting a selectively inflatable occlusion balloon on the main body of the dilator, and before the step of selectively coupling the first source of pressurized fluid to the first passageway, movably advancing the main body of the dilator relative to the sheath so as to locate the occlusion balloon longitudinally outwardly relative to the second end of the sheath.   
     
     
         19 . A method as claimed in  claim 17 , and which further comprises:
 before the step of selectively coupling the second source of the pressurized fluid to the second passageway, movably advancing the main body of the dilator relative to the sheath so as to locate the terminal end of the second passageway longitudinally outwardly relative to the second end of the sheath.   
     
     
         20 . A method for gaining access to the body cavity of a patient, comprising:
 inserting an elongated needle, at least in part, into a body cavity of a patient, and wherein the elongated needle has a proximal and distal end, and further has a longitudinally oriented passageway which extends between the proximal and distal ends thereof;   inserting a wire into the longitudinally extending passageway of the elongated needle, and advancing the inserted wire through the needle, and further orienting a portion of the wire in the body cavity which is being accessed;   after the step of inserting a portion of the wire into the body cavity which is being accessed, removing the needle from the body cavity by passing the needle over the wire, and simultaneously leaving the portion of the wire previously inserted in the body cavity which is being accessed, within the body cavity;   providing a sheath having opposite first, and second ends, and a longitudinally extending passageway which extends between the opposite first and second ends, and wherein the longitudinally extending passageway of the sheath has a predetermined inside diametral dimension, and wherein the method further includes passing the wire, at least in part, through the longitudinally extending passageway of the sheath, and further moveably advancing the sheath along the wire, and inserting the second end of the sheath within the body cavity which is being accessed;   after the step of providing the sheath, the method includes another step of removing the wire from the body cavity which is being accessed by forcibly withdrawing the wire through the longitudinally extending passageway which is defined by the sheath;   after the step of removing the wire from the body cavity, the method further includes a step of providing an elongated dilator having a main body which has an outside diametral dimension which is less than the inside diametral dimension of the longitudinally extending passageway which is defined by the elongated sheath, and wherein the main body of the elongated dilator further has opposite, first and second ends, and a longitudinally oriented lumen which extends between the opposite first and second ends of the main body, and wherein the main body of the elongated dilator further has an outside facing surface, and wherein a first and second passageway is individually formed in the main body of the elongated dilator, and wherein each of the first and second passageways have a proximal, and a distal end, and which further, respectively, extend from the first end thereof, and in the direction of the second end of the main body, and wherein the method further includes the step of telescopingly inserting the main body of the dilator within the longitudinally extending passageway which is defined by the sheath, and longitudinally advancing the dilator along the longitudinally extending passageway which is defined by the sheath, and orienting the second end of the dilator at a location which is longitudinally, outwardly relative to the second end of the sheath, and within the body cavity being accessed, and wherein the dilator is selectively, reciprocally, and longitudinally moveable relative to the second end of the elongated sheath;   providing a selectively inflatable occlusion balloon, and mounting the occlusion balloon on the dilator at a location which is intermediate the first and second ends of the main body thereof, and further coupling the dilator balloon in selective, fluid flowing relation relative to the distal end of the first passageway which is formed in the main body of the elongated dilator, and wherein the method further includes longitudinally advancing the occlusion balloon relative to the dilator to a position where the occlusion balloon is located longitudinally, outwardly, relative to the second end of the elongated sheath, and wherein the second passageway which is formed in the outside facing surface of the main body of the dilator extends from the first end thereof, and the distal end of the second passageway terminates at a location which is adjacent to, but short of the selectively inflatable occlusion balloon, and wherein the main body of the elongated dilator is selectively, longitudinally advanced relative to the sheath so as to position both the occlusion balloon, and the distal end of the second passageway, and which is formed in the main body of the elongated dilator, at a location which is longitudinally, outwardly relative to the second end of the sheath;   providing a first source of a pressurized fluid and coupling the first source of pressurized fluid in selective, fluid delivering relation relative to the proximal end of the first passageway of the elongated dilator, and delivering the first source of the pressurized fluid to the proximal end of the first passageway so as to effect an inflation of the occlusion balloon within the body cavity which is being accessed; and   providing a second source of a pressurized fluid, and coupling the second source of the pressurized fluid in selective, fluid delivering relation relative to the proximal end of the second passageway of the elongated dilator, and wherein the method further includes the step of delivering the second source of pressurized fluid to the second passageway, for movement therealong to the distal end of the second passageway, and further depositing the second source of the pressurized fluid within the body cavity being accessed, and wherein the second source of pressurized fluid exists the elongated dilator in a direction which is oriented laterally, outwardly relative thereto, and into the body cavity being accessed.